Parkinson DiseaseNCT06655727
Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound
An observational study of Parkinson Disease, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Ultrasound evaluation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2024to 15 Nov 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Parkinson's Disease and healthy controls
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease by a neurologist.
- Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
- Scoring at least 24 on the Mini-Mental State Examination (MMSE).
- Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.
Who cannot join
- Presence of head or neck cancer that could cause dysphagia.
- History of radiotherapy or surgery in the head and neck region.
- Diagnosis of vascular parkinsonism or stroke.
- Presence of cardiopulmonary disease that could affect swallowing or breathing.
- Having received voice or swallowing therapy in the last 6 months.
- Presence of a diagnosed psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study
The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.
Read the detailed description
Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).
- Conditions
- Parkinson Disease
- Being tested
- Ultrasound evaluation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound evaluationDiagnostic test
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Parkinson disease group | Patients with Parkinson's disease Receives: Diagnostic Test: Ultrasound evaluation | |
| Control group | Healthy volunteers Receives: Diagnostic Test: Ultrasound evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EAT-10 (Eating Assessment Tool-10)
The EAT-10 (Eating Assessment Tool-10) is a validated self-administered questionnaire designed to assess symptoms of dysphagia (difficulty swallowing). It consists of 10 questions that evaluate the severity of swallowing difficulties, including issues related to eating, drinking, and managing saliva. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (severe problem). A total score of 3 or higher suggests the presence of clinically significant dysphagia, and it helps guide further diagnostic evaluation and management.
Measured: 0 day
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS is a comprehensive tool used to evaluate the severity and progression of Parkinson's disease. It consists of multiple sections assessing motor and non-motor symptoms, helping clinicians understand the impact of the disease on daily functioning. The UPDRS is widely used in both clinical practice and research to monitor disease progression and treatment effects.
In the MDS-UPDRS, higher scores indicate more severe Parkinson's disease symptoms. Each item is rated from 0 (normal) to 4 (severe), with the total score reflecting the overall disease severity. A higher total score means worse motor and non-motor symptoms, indicating greater impairment and reduced quality of life. Lower scores suggest milder symptoms and better functional status.
Measured: 0 day
Secondary outcomes (3)
Tongue Thickness
Tongue thickness refers to the measurement of the width or thickness of the tongue in centimeters. This parameter is evaluated using ultrasound to assess the muscle mass and structural integrity of the tongue, which plays a critical role in swallowing function. In conditions like dysphagia, reduced tongue thickness may indicate weakened tongue muscles, contributing to swallowing difficulties.
Measured: 0 day
Distance Between the Hyoid and Mandible
This is the measurement of the space between the hyoid bone and the mandible (lower jaw) while the individual is at rest or during swallowing. It is typically measured in centimeters and can provide insights into the positioning and movement of structures involved in swallowing. An abnormal distance between these structures may indicate dysfunction in the swallowing mechanism.
Measured: 0 day
Hyoid Displacement Distance:
The hyoid bone plays a key role in the swallowing process by facilitating the elevation and forward movement of the larynx. Insufficient hyoid displacement can lead to impaired swallowing function, as it affects the coordination of muscles involved in the swallow. The measurement of this displacement helps assess the efficiency and safety of the swallowing mechanism.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start25 Oct 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655727
- Sponsor's protocol ID
- BeylikduzuStateH5
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dysphagia in Patients Diagnosed With Parkinson's Disease by Ultrasound: A Controlled Study
- ClinicalTrials.gov ID
- NCT06655727
- Acronym / sponsor ID
- BeylikduzuStateH5
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to perform an ultrasonographic swallowing assessment in Parkinson's patients and healthy volunteers and compare the findings with those from clinical swallowing evaluations. The secondary aim is to examine the relationship between dysphagia and functional status.
Detailed description
Thirty patients aged 40-80 years, diagnosed with idiopathic Parkinson's disease (Modified Hoehn-Yahr stage 1-3), and thirty healthy volunteers who either applied to the Physical Therapy and Rehabilitation outpatient clinic or received inpatient rehabilitation at Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital will be included in this study. At the start of the study, sociodemographic data of both patients and volunteers will be recorded. The Mini-Mental Test and the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) will be used to evaluate the mental and functional status of the patients diagnosed with Parkinson's disease. After the clinical dysphagia evaluation, the EAT-10 questionnaire will be administered to the participants. Following this, an ultrasonographic swallowing assessment will be performed on the participants. The ultrasonographic measurements will include tongue thickness (cm), resting distance between the mandible and hyoid (cm), shortest distance between the mandible and hyoid (cm), hyoid displacement (cm), hyoid displacement percentage, tongue thickness (cm) (with 5ml of water), resting distance between the mandible and hyoid (cm) (with 5ml of water), shortest distance between the mandible and hyoid (cm) (with 5ml of water), hyoid displacement (cm) (with 5ml of water), and hyoid displacement percentage (%) (with 5ml of water).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson disease group | – | Diagnostic Test: Ultrasound evaluationPatients with Parkinson's disease |
| Control group | – | Diagnostic Test: Ultrasound evaluationHealthy volunteers |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease and healthy controls
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic Parkinson's disease by a neurologist.
- Being in stages 1-3 according to the Modified Hoehn-Yahr Staging Scale.
- Scoring at least 24 on the Mini-Mental State Examination (MMSE).
- Not having received any therapy or treatment affecting swallowing, other than routine medication for Parkinson's disease.
Key exclusion criteria (6 listed)
- Presence of head or neck cancer that could cause dysphagia.
- History of radiotherapy or surgery in the head and neck region.
- Diagnosis of vascular parkinsonism or stroke.
- Presence of cardiopulmonary disease that could affect swallowing or breathing.
- Having received voice or swallowing therapy in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound evaluationNo intervention | Diagnostic test | Control group, Parkinson disease group |
Primary outcome
The EAT-10 (Eating Assessment Tool-10)
Time frame: 0 day
The EAT-10 (Eating Assessment Tool-10) is a validated self-administered questionnaire designed to assess symptoms of dysphagia (difficulty swallowing). It consists of 10 questions that evaluate the severity of swallowing difficulties, including issues related to eating, drinking, and managing saliva. Each item is rated on a 5-point scale, ranging from 0 (no problem) to 4 (severe problem). A total score of 3 or higher suggests the presence of clinically significant dysphagia, and it helps guide further diagnostic evaluation and management.
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 0 day
The UPDRS is a comprehensive tool used to evaluate the severity and progression of Parkinson's disease. It consists of multiple sections assessing motor and non-motor symptoms, helping clinicians understand the impact of the disease on daily functioning. The UPDRS is widely used in both clinical practice and research to monitor disease progression and treatment effects. In the MDS-UPDRS, higher scores indicate more severe Parkinson's disease symptoms. Each item is rated from 0 (normal) to 4 (severe), with the total score reflecting the overall disease severity. A higher total score means worse motor and non-motor symptoms, indicating greater impairment and reduced quality of life. Lower scores suggest milder symptoms and better functional status.
3 secondary outcomes
Tongue Thickness
Time frame: 0 day
Distance Between the Hyoid and Mandible
Time frame: 0 day
Hyoid Displacement Distance:
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EAT-10 (Eating Assessment Tool-10) (time frame: 0 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.